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riociguat (Adempas, Bayer) for the treatment of Chronic Thromboembolic Pulmonary Hypertension (CTEPH) and Pulmonary Arterial Hypertension (PAH) – Approved by FDA 10/2013

Reporter: Aviva Lev-Ari, PhD, RN

Yes to Riociguat for CTEPH and PAH

In contrast to serelaxin, CHMP issued a favorable opinion on riociguat (Adempas, Bayer) and recommended marketing authorization of the drug for the treatment of chronic thromboembolic pulmonary hypertension (CTEPH) and pulmonary arterial hypertension (PAH) ^[2] .

Riociguat is a vasodilator that restores the nitric-oxide–soluble guanylate cyclase-cyclic guanosine monophosphate (NO-sGC-cGMP) pathway by directly stimulating sGC independent of NO and sensitizing sGC to low levels of NO. In two phase 3 trials, which were reported by heart wire, treatment with riociguat resulted in significant improvements in exercise capacity and pulmonary hemodynamics in patients with pulmonary hypertension.

“The CHMP, on the basis of quality, safety, and efficacy data submitted, considers there to be a favorable benefit-to-risk balance for Adempas and therefore recommends the granting of the marketing authorization.”

The intended indication is for CTEPH patients with World Health Organization (WHO) functional class 2 or 3 and inoperable CTEPH or persistent or recurrent CTEPH after surgery. For PAH patients with WHO functional class 2 or 3, riociguat’s intended indication is as monotherapy or in combination with endothelin-receptor antagonists. Both indications are for the improvement of exercise capacity.

In October 2013, the US Food and Drug Administration (FDA) approved riociguat for the treatment of PAH and the treatment of chronic CTEPH.

REFERENCES

European Medicines Agency. Riociguat (Adempas): Summary of opinion. January 24, 2014. Available here.

SOURCE

http://www.medscape.com/viewarticle/819683?nlid=46423_2562&src=wnl_edit_medp_card&uac=93761AJ&spon=2

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Clinical Trials Results for Endothelin System: Pathophysiological role in Chronic Heart Failure, Acute Coronary Syndromes and MI – Marker of Disease Severity or Genetic Determination?

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